Accuracy of Hemoglobin Measurement for Various Rainbow Pulse Oximeter Sensors

Masimo

Status

Completed

Conditions

Healthy

Treatments

Device: Pulse Oximeter sensor

Study type

Interventional

Funder types

Industry

Identifiers

NCT03124966

TR19443-56044

Details and patient eligibility

About

In this study, the concentration of hemoglobin within the subject's blood will be reduced in a controlled manner by administering fluids intravenously. The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.

Enrollment

118 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Study Site 1:

Inclusion Criteria:

Has physical status between ASA 1 or 2
Able to communicate in English

Exclusion Criteria:

Pregnant or sexually active without birth control.
Hemoglobin less than 11g/dL
Known alcohol or drug abuse
Skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection
Nail polish
Head injury with loss of consciousness within the last year
Known neurological and psychiatric conditions.
Known concurrent chronic usage of psychoactive or anti-convulsive drugs within the last 90 days, or use in the last 7 days (i.e. tricyclic antidepressants, MAO inhibitors, lithium, neuroleptics, anxiolytics or antipsychotics. Except SSRIs
Subject has any medical condition which, in the judgement of the investigator, renders them inappropriate for participation in this study, such as Raynaud's syndrome
Hypertension: Systolic BP >= 140 mmHg or Diastolic BP >= 90 mmHg
Baseline heart rate <50 beats per minute

Study Site 2:

Inclusion Criteria:

Male or female
18-35 years of age
Physical status of ASA I or II
Able to read and communicate in English
Has signed written informed consent
If female, non pregnant. If female subject is currently sexually active and not on birth control they must have a negative pregnancy test prior to study enrollment.

Exclusion Criteria

Age less than 18 yrs and greater than 35 years
Hemoglobin less than 12 g/dL
ASA physical status of III, IV, or V
Pregnant or sexually active without birth control
Subject has known drug or alcohol abuse
Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails.
Subject has experienced a head injury with loss of consciousness within the last year
Subject has known neurological and psychiatric disorder that interferes with the subjects level of consciousness
Known or concurrent chronic usage of psychoactive or anticonvulsive drugs within the last 90 days, or any use in the last 7 day (i.e. tricyclic antidepressants, MAO inhibitors, lithium, neuroleptics, anxiolytics or antipsychotics, except SSRIs).
Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study, such as Raynauds Syndrome.
Hypertension: Systolic BP >140 mmHg or Diastolic BP > 90 mmHg.
Baseline heart rate < 50 bpm.
Inability to tolerate sitting still or minimal movement for up to 90 minutes